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IRBs might help board members improve their protocol review process through the use of a tool that guides them through questions to ask about each study.
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As often happens in research, new rules, policies, and guidelines often follow media reports of research integrity and ethical breaches.
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When attempting to activate a clinical trial, one of the biggest concerns an institution faces is turnaround time. At Cedars-Sinai Medical Center in Los Angeles, activation of a new clinical trial could sometimes take 118 days, including IRB review, study team response time, and non-IRB required reviews such as contract negotiations. But for some protocols, including early-stage oncology or therapeutic studies, the institution looked for other ways to bring those new therapies to patients as efficiently and safely as possible.
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Creating clear, truly understandable informed consent documentation can sometimes be a challenge for IRB members and researchers, particularly in the area of international research. Making sure that details are not lost in translation and that the documentation meets U.S. federal and international regulations can also present some difficulty.
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Assessing risks and benefits is an evolving process in the human research protection world especially for IRBs that handle social-behavioral, as well as biomedical, studies. One size in risk-benefit assessment definitely does not fit all. For instance, IRBs sometimes over-emphasize risks in studies involving social-behavioral topics without considering protections that researchers have put in place, IRB experts say.
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A new year means new provisions to be put in in place under the Affordable Care Act, the National Association of Healthcare Access Management reports.
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If youre the one who tells self-pay patients their bill is in the six figures without offering any assistance, theyre very likely to blame the messenger and become defensive. On the other hand, what if you could give those patients peace of mind by helping them obtain desperately needed coverage?
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Electronic health records (EHRs) have long been touted as a transformative tool in medicine.
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A growing number of public hospitals are engaging their patients in a conversation on how to improve service, according to the National Association of Healthcare Access Management (NAHAM), which refers to a story in Modern Healthcare.
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Get out of my room! Im not signing any paperwork. How you get paid is your problem, not mine. Thats what a self-pay patient who required open heart surgery told a case manager at Trinity Rock Island (IL).
